Skip to main content
OpenTrials
Completed

NCT Number: NCT06775392

Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Comparative Evaluation of Bromelain-Quercetin Gel With Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing In Stage I /II and Grade B Periodontitis - Randomized Control Clinical Trail

Completed

Looking for future studies?

Notify Me

Key information

Age range

30 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Dr. NALLAGATLA VAMSI VENKATA KRISHNA SAI

Bengaluru, Karnataka, 562157, India

About this study

: Periodontitis is a biofilm associated disease that induces an irreversible inflammatory state that leads to the destruction of the supporting structure of the teeth. Management of periodontal disease is through thorough removal of biofilm which is pivotal for having better oral health. Scaling and root planning (SRP) is fundamental treatment for periodontitis. Years of documented research have established that chlorhexidine digluconate (CHX), gold standard of chemical plaque control agent is safe stable and effective in preventing and controlling plaque formation. Bromelain is an extract derived from Ananas comosus (popularly known as pineapple), contains proteinases that exhibits anti-inflammatory properties, antibacterial effect against periodontopathogens. Bromelain gel has shown to have chemicomechanical method of caries removal. Quercetin present in guava have excellent antibacterial actions against periodontal pathogens, Aggregatibacter actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) and Fusobacterium nucleatum (Fn). 2% Quercetin has shown to be advantageous for subgingival application after scaling and rootplaning. Bromelain-Quercetin gel has shown adjunctive effect for treatment in covid-19 patients. As there is less literature in this combination, we intend to study its effects. Individually bromelain and quercetin have been studied for treatment in oral cavity as gel form. This study will be first of its kind to check the efficacy of 2% bromelain-quercetin gel and to compare its effects with 0.2% Chlorhexidine in stage I/II and grade B periodontits.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with have chronic periodontitis in the age group between 30-50 years.
  • Patients having ≥20 teeth.

-.Patients with radiographic evidence of bone loss in atleast two teeth.

  • Patients who are systematically healthy.
  • Patients with localized pockets with probing depth of ≤ 5mm.
  • Patients who are cooperative and able to attend the hospital for regular follow-up.

Exclusion criteria

  • Patients who have received any surgical or nonsurgical therapy during past 6months
  • Pregnant or lactating females.
  • Use of systemic antibiotics in the past 6 months.
  • Patient who are not willing to give a written informed consent

Treatment and study plan

bromelain-quercetin gel

Drug

bromelain-quercetin gel is prepared from capsules in laboratory

chlorhexidine gel

Drug

chlorhexidine gel is prepared in laboratory

SRP

Procedure

Scaling and root planing was done with ultra sonic and hand scaling

Primary outcomes

  1. PROBING POCKET DEPTH

    Time frame: 21DAYS

    measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

  2. CLINICAL ATTACHMENT LEVEL

    Time frame: 21DAYS

    (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)

Secondary outcomes

  1. Plaque Index

    Time frame: 21DAYS

    measured on the tooth surface using a probe

  2. Gingival index

    Time frame: 21DAYS

    measured on the tooth surface using a probe

  3. Modified Sulcus Bleeding Index

    Time frame: 21days

    measured on the tooth surface using a probe

Sponsors and collaborators

Lead sponsor

Krishnadevaraya College of Dental Sciences & Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 15, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.